AR089666A1 - STABLE PHARMACEUTICAL FORMULATION FOR ORAL ADMINISTRATION INCLUDING LEVOCETIRIZINE OR ONE OF ITS ACCEPTABLE SALTS FROM THE PHARMACEUTICAL VIEWPOINT, AND MONTELUKAST OR ONE OF ITS ACCEPTABLE SALTS FROM THE PHARMACEUTICAL VIEWPOINT - Google Patents
STABLE PHARMACEUTICAL FORMULATION FOR ORAL ADMINISTRATION INCLUDING LEVOCETIRIZINE OR ONE OF ITS ACCEPTABLE SALTS FROM THE PHARMACEUTICAL VIEWPOINT, AND MONTELUKAST OR ONE OF ITS ACCEPTABLE SALTS FROM THE PHARMACEUTICAL VIEWPOINTInfo
- Publication number
- AR089666A1 AR089666A1 ARP130100039A ARP130100039A AR089666A1 AR 089666 A1 AR089666 A1 AR 089666A1 AR P130100039 A ARP130100039 A AR P130100039A AR P130100039 A ARP130100039 A AR P130100039A AR 089666 A1 AR089666 A1 AR 089666A1
- Authority
- AR
- Argentina
- Prior art keywords
- acceptable salts
- pharmaceutical
- viewpoint
- montelukast
- oral administration
- Prior art date
Links
- 150000003839 salts Chemical class 0.000 title abstract 4
- ZKLPARSLTMPFCP-OAQYLSRUSA-N 2-[2-[4-[(R)-(4-chlorophenyl)-phenylmethyl]-1-piperazinyl]ethoxy]acetic acid Chemical compound C1CN(CCOCC(=O)O)CCN1[C@@H](C=1C=CC(Cl)=CC=1)C1=CC=CC=C1 ZKLPARSLTMPFCP-OAQYLSRUSA-N 0.000 title abstract 3
- UCHDWCPVSPXUMX-TZIWLTJVSA-N Montelukast Chemical compound CC(C)(O)C1=CC=CC=C1CC[C@H](C=1C=C(\C=C\C=2N=C3C=C(Cl)C=CC3=CC=2)C=CC=1)SCC1(CC(O)=O)CC1 UCHDWCPVSPXUMX-TZIWLTJVSA-N 0.000 title abstract 3
- 229960001508 levocetirizine Drugs 0.000 title abstract 3
- 229960005127 montelukast Drugs 0.000 title abstract 3
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 3
- 150000007524 organic acids Chemical class 0.000 abstract 2
- 239000002245 particle Substances 0.000 abstract 2
- 206010039085 Rhinitis allergic Diseases 0.000 abstract 1
- 201000009961 allergic asthma Diseases 0.000 abstract 1
- 201000010105 allergic rhinitis Diseases 0.000 abstract 1
- 208000006673 asthma Diseases 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 239000003381 stabilizer Substances 0.000 abstract 1
- 239000000126 substance Substances 0.000 abstract 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4704—2-Quinolinones, e.g. carbostyril
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
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- A—HUMAN NECESSITIES
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/4965—Non-condensed pyrazines
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P27/14—Decongestants or antiallergics
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- A—HUMAN NECESSITIES
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- A61P37/08—Antiallergic agents
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A—HUMAN NECESSITIES
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
Abstract
La presente se refiere a una formulación farmacéutica para administración oral para prevenir o tratar la rinitis alérgica o el asma, que comprende: (a) una primera parte de partículas que comprende levocetirizina o una de sus sales aceptables desde el punto de vista farmacéutico y un ácido orgánico; y (b) una segunda parte de partículas que comprende montelukast o una de sus sales aceptables desde el punto de vista farmacéutico. La formulación farmacéutica de acuerdo con la presente comprende un ácido orgánico como agente estabilizador, que puede inhibir en forma efectiva la producción de levocetirizina y sustancias relacionadas con montelukast, y de este modo, muestran buena estabilidad.This refers to a pharmaceutical formulation for oral administration to prevent or treat allergic rhinitis or asthma, comprising: (a) a first part of particles comprising levocetirizine or a pharmaceutically acceptable salt thereof and a organic acid; and (b) a second part of particles comprising montelukast or a pharmaceutically acceptable salt thereof. The pharmaceutical formulation according to the present invention comprises an organic acid as a stabilizing agent, which can effectively inhibit the production of levocetirizine and substances related to montelukast, and thus, show good stability.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR1020120001954A KR101418404B1 (en) | 2012-01-06 | 2012-01-06 | Stable pharmaceutical formulation for oral administration comprising levocetirizine or a pharmaceutically acceptable salt thereof, and montelukast or a pharmaceutically acceptable salt thereof |
Publications (1)
Publication Number | Publication Date |
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AR089666A1 true AR089666A1 (en) | 2014-09-10 |
Family
ID=48745292
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ARP130100039A AR089666A1 (en) | 2012-01-06 | 2013-01-04 | STABLE PHARMACEUTICAL FORMULATION FOR ORAL ADMINISTRATION INCLUDING LEVOCETIRIZINE OR ONE OF ITS ACCEPTABLE SALTS FROM THE PHARMACEUTICAL VIEWPOINT, AND MONTELUKAST OR ONE OF ITS ACCEPTABLE SALTS FROM THE PHARMACEUTICAL VIEWPOINT |
Country Status (21)
Country | Link |
---|---|
US (1) | US9486528B2 (en) |
EP (1) | EP2800558B1 (en) |
JP (1) | JP6163165B2 (en) |
KR (1) | KR101418404B1 (en) |
CN (1) | CN104039314B (en) |
AR (1) | AR089666A1 (en) |
BR (1) | BR112014016472B1 (en) |
ES (1) | ES2671428T3 (en) |
HK (1) | HK1200337A1 (en) |
JO (1) | JO3388B1 (en) |
MX (1) | MX354073B (en) |
PH (1) | PH12014501545A1 (en) |
PL (1) | PL2800558T3 (en) |
PT (1) | PT2800558T (en) |
RU (1) | RU2614382C2 (en) |
SG (1) | SG11201403811VA (en) |
SI (1) | SI2800558T1 (en) |
TR (1) | TR201807978T4 (en) |
TW (1) | TWI565482B (en) |
WO (1) | WO2013103262A1 (en) |
ZA (1) | ZA201405756B (en) |
Families Citing this family (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9717684B2 (en) | 2014-04-25 | 2017-08-01 | R.P. Scherer Technologies, Llc | Stable montelukast solution |
KR101669556B1 (en) * | 2014-07-02 | 2016-10-28 | 한미약품 주식회사 | Liquid Formulation of Montelukast or Pharmaceutically Acceptable Salt Thereof for Oral Administration |
JP6575031B2 (en) * | 2014-07-28 | 2019-09-18 | 日本ケミファ株式会社 | Montelukast sodium preparation |
RU2580303C1 (en) * | 2015-02-18 | 2016-04-10 | Общество с ограниченной ответственностью "ПРОФИТ ФАРМ" | Composition of pellet drug with proroxanum active ingredient |
PL3222279T3 (en) | 2016-03-21 | 2022-05-09 | Invest Bielany Spółka Z Ograniczoną Odpowiedzialnością | Oral pharmaceutical formulation of montelukast and levocetirizine and method for its production |
KR102481517B1 (en) * | 2021-08-30 | 2022-12-27 | 주식회사 클라시아 | Pharmaceutical Formulation |
WO2023068839A1 (en) * | 2021-10-21 | 2023-04-27 | 한화제약주식회사 | Film-coated tablet with improved stability containing montelukast or pharmaceutically acceptable salt thereof and levocetirizine or pharmaceutically acceptable salt thereof |
KR20240045586A (en) | 2022-09-30 | 2024-04-08 | 주식회사 제뉴원사이언스 | Bilayer tablets with enhanced stability comprising levocetirizine or pharmaceutically acceptable salt thereof and montelukast or pharmaceutically acceptable salt thereof and method for preparing the same |
Family Cites Families (17)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB1204580A (en) | 1968-10-05 | 1970-09-09 | Aspro Nicholas Ltd | Pharmaceutical dosage forms |
NO155805C (en) | 1981-02-06 | 1987-06-10 | Ucb Sa | ANALOGY PROCEDURE FOR THE PREPARATION OF THERAPEUTIC ACTIVITY 2- (4- (DIPHENYLMETHYL) -1-PIPERAZINYL) -ACDIC ACIDS AND THEIR AMIDS AND NON-TOXIC SALTS. |
US4800162A (en) | 1987-04-01 | 1989-01-24 | Sepracor, Inc. | Method for resolution of steroisomers in multiphase and extractive membrane reactors |
US5057427A (en) | 1988-04-07 | 1991-10-15 | Sepracor, Inc. | Method for resolution of stereoisomers |
GB8827390D0 (en) | 1988-11-23 | 1988-12-29 | Ucb Sa | Process for preparation of 2-(2-(4-((4-chlorophenyl)phenylmethyl)-1-pipera-zinyl)ethoxy)-acetic acid & its dihydrochloride |
GB8827391D0 (en) | 1988-11-23 | 1988-12-29 | Ucb Sa | Process for preparation of 2-(2-(4-((4-chlorophenyl)phenylmethyl)-1-pipera-zinyl)ethoxy)-acetic acid & its dihydrochloride |
DE4209824A1 (en) | 1991-09-06 | 1993-03-11 | Schaeffler Waelzlager Kg | ROLLER BEARING FOR LINEAR MOVEMENTS |
GB9305282D0 (en) | 1993-03-15 | 1993-05-05 | Ucb Sa | Enantiomers of 1-(4-chlorophenyl)phenylmethyl)-4-(4-methylphenyl)sulphonyl)piperazine |
BE1010094A3 (en) | 1996-04-10 | 1997-12-02 | Ucb Sa | NEW [2- (1-piperazinyl) ethoxy] SUBSTITUTED. |
BE1010095A3 (en) | 1996-04-10 | 1997-12-02 | Ucb Sa | METHOD OF PREPARATION OF ACID 2- [2- [4 - [(4-Chlorophenyl) phenylmethyl] -1-PIPERAZINYL] ETHOXY] acetic acid AND ITS SALTS. |
DE10007203A1 (en) * | 2000-02-17 | 2001-08-23 | Asta Medica Ag | Composition for treating allergic and/or vasomotor rhinitis or allergic conjunctivitis by topical or oral administration, contains synergistic combination of non-sedating antihistamine and leukotriene antagonist |
AU2001250206A1 (en) | 2000-04-12 | 2001-10-30 | Merck Frosst Canada Ltd | Method and compositions for the treatment of allergic conditions using pgd2 receptor antagonists |
KR100795419B1 (en) | 2006-01-03 | 2008-01-17 | (주)네오메딕스 | Pharmaceutical formulation containing amlodipine and aspirin |
KR100910848B1 (en) * | 2007-09-13 | 2009-08-06 | 재단법인서울대학교산학협력재단 | Microsphere for nasal spray comprising drug for treating allergic rhinitis and preparation method thereof |
WO2010107404A1 (en) * | 2009-03-16 | 2010-09-23 | Mahmut Bilgic | Stable pharmaceutical combinations |
KR20130009553A (en) | 2011-07-15 | 2013-01-23 | 한미약품 주식회사 | Capsule formulation comprising montelukast or a pharmaceutically acceptable salt thereof, and levocetirizine or a pharmaceutically acceptable salt thereof |
KR101861307B1 (en) * | 2011-10-13 | 2018-07-06 | 한미약품 주식회사 | Composite formulation comprising a tablet encapsulated in a hard capsule |
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2012
- 2012-01-06 KR KR1020120001954A patent/KR101418404B1/en active IP Right Grant
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2013
- 2013-01-03 JO JOP/2013/0004A patent/JO3388B1/en active
- 2013-01-04 PT PT137337895T patent/PT2800558T/en unknown
- 2013-01-04 RU RU2014132428A patent/RU2614382C2/en not_active IP Right Cessation
- 2013-01-04 AR ARP130100039A patent/AR089666A1/en not_active Application Discontinuation
- 2013-01-04 US US14/370,258 patent/US9486528B2/en active Active
- 2013-01-04 CN CN201380004854.0A patent/CN104039314B/en active Active
- 2013-01-04 JP JP2014551191A patent/JP6163165B2/en not_active Expired - Fee Related
- 2013-01-04 ES ES13733789.5T patent/ES2671428T3/en active Active
- 2013-01-04 SG SG11201403811VA patent/SG11201403811VA/en unknown
- 2013-01-04 MX MX2014008059A patent/MX354073B/en active IP Right Grant
- 2013-01-04 TR TR2018/07978T patent/TR201807978T4/en unknown
- 2013-01-04 SI SI201331005T patent/SI2800558T1/en unknown
- 2013-01-04 BR BR112014016472-0A patent/BR112014016472B1/en active IP Right Grant
- 2013-01-04 EP EP13733789.5A patent/EP2800558B1/en active Active
- 2013-01-04 PL PL13733789T patent/PL2800558T3/en unknown
- 2013-01-04 TW TW102100251A patent/TWI565482B/en not_active IP Right Cessation
- 2013-01-04 WO PCT/KR2013/000057 patent/WO2013103262A1/en active Application Filing
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2014
- 2014-07-03 PH PH12014501545A patent/PH12014501545A1/en unknown
- 2014-08-05 ZA ZA2014/05756A patent/ZA201405756B/en unknown
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2015
- 2015-01-23 HK HK15100824.5A patent/HK1200337A1/en not_active IP Right Cessation
Also Published As
Publication number | Publication date |
---|---|
MX354073B (en) | 2018-02-12 |
KR20130081013A (en) | 2013-07-16 |
RU2614382C2 (en) | 2017-03-24 |
ZA201405756B (en) | 2016-08-31 |
US9486528B2 (en) | 2016-11-08 |
JP6163165B2 (en) | 2017-07-12 |
CN104039314A (en) | 2014-09-10 |
SG11201403811VA (en) | 2014-08-28 |
BR112014016472A8 (en) | 2017-07-04 |
ES2671428T3 (en) | 2018-06-06 |
TR201807978T4 (en) | 2018-06-21 |
BR112014016472A2 (en) | 2017-06-13 |
SI2800558T1 (en) | 2018-06-29 |
WO2013103262A1 (en) | 2013-07-11 |
KR101418404B1 (en) | 2014-07-10 |
PH12014501545B1 (en) | 2014-10-08 |
EP2800558A1 (en) | 2014-11-12 |
EP2800558A4 (en) | 2015-08-12 |
PL2800558T3 (en) | 2018-08-31 |
TW201332590A (en) | 2013-08-16 |
TWI565482B (en) | 2017-01-11 |
US20140356422A1 (en) | 2014-12-04 |
RU2014132428A (en) | 2016-02-27 |
BR112014016472B1 (en) | 2022-03-15 |
HK1200337A1 (en) | 2015-08-07 |
JP2015503579A (en) | 2015-02-02 |
JO3388B1 (en) | 2019-03-13 |
PH12014501545A1 (en) | 2014-10-08 |
EP2800558B1 (en) | 2018-04-11 |
MX2014008059A (en) | 2014-10-06 |
CN104039314B (en) | 2017-07-14 |
PT2800558T (en) | 2018-06-05 |
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